I. Determine, by observing the 5-year survival and disease-free interval, the
validity of current FIGO staging to the histopathologic factors of size of
lesion, location of lesion, depth of invasion, histology and grade, growth
pattern, and site and number of positive nodes in Stage IB carcinoma of the
cervix.
II. Accumulate prospectively significant surgical pathologic data that would
expedite development of further protocols.
III. Determine the morbidity of primary radical surgical therapy in these
patients.
IV. Determine whether radiotherapy improves survival in patients with
unilateral metastasis to no more than 3 pelvic nodes when there is no
parametrial involvement and there are clear vaginal margins.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients with
histologically proven invasive Stage IB carcinoma of the cervix (squamous
cell, adenocarcinoma, or adenosquamous). There may be no past or concurrent
malignancy aside from nonmelanomatous skin cancer.

Expected Enrollment

About 250-400 patients will be accrued annually, of whom about 10 percent will
be eligible for the randomized portion of the study; the randomized part of
the study will require 135 patients per arm over 8-9 years. Protocol closed
February 1984.

Outline

Randomized study. Per April 1983 amendment, patients must be randomized no
later than 8 weeks following surgery.
Regimen A: Surgery.
Arm I: Radiotherapy. Co-60 teletherapy or other supervoltage treatment.
Arm II: No further treatment.

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.